partial AUCs for locally acting MR [Design Issues]

posted by jag009  – NJ, 2020-12-05 08:01 (315 d 22:46 ago) – Posting: # 22116
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Hi,

» I’m involved in the development of a MR generic drug that is locally acting in the GI tract. Despite the very helpful new EMA guideline (Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract, CPMP/EWP/239/95 Rev. 1, Corr.1*) I´m struggling with designing the BE studies to support submission in EU.
»
» Most problematic is the justification of the cut-off for the required partial AUCs.

Something like this in US for mesalamine ER?

https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf

J

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